BrainPulse 1100
K-Number: K170926 · 2017-04-28
ApplicantJan Medical, Inc.
Decision Date2017-04-28
Product CodePOP
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
BrainPulse 1100 is a medical device manufactured by Jan Medical, Inc.. It received FDA 510(k) clearance on 2017-04-28 under approval number K170926. The device is classified under product code POP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BrainPulse 1100?
BrainPulse 1100 is a medical device that received FDA 510(k) clearance on 2017-04-28. It is manufactured by Jan Medical, Inc.. The 510(k) number is K170926.
When was BrainPulse 1100 approved by the FDA?
BrainPulse 1100 received FDA 510(k) clearance on 2017-04-28, under approval number K170926.
What company makes BrainPulse 1100?
BrainPulse 1100 is manufactured by Jan Medical, Inc..
What is the FDA product code for BrainPulse 1100?
The FDA product code for BrainPulse 1100 is POP.
Other Devices by Jan Medical, Inc.
Related Devices (Code: POP)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.